Finding the Patient's Voice Diabetes Prevention Programs

Finding the Patient's Voice: Development of Practical Approaches for Adolescent and Family Focused Diabetes Prevention Programs

This study uses patient engagement to develop a diabetes prevention program focused on adolescents and families.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Prediabetic State
• Intervention / Treatment: Behavioral: Encourage 2.0

Detailed Description

Due to increases in obesity, the onset of type 2 diabetes is occurring at an ever-younger age, and is associated with poor outcomes and rising costs, which emphasizes the need for prevention at earlier ages. To address this need, the investigators designed the ENCOURAGE Healthy Families curriculum; a program based on the scientifically proven U.S. Diabetes Prevention Program, and while data demonstrate a reduction in obesity and diabetes risk for mothers and their children, the investigators have encountered several barriers to widespread implementation, including:

1. helping youth/families understand the importance of prevention,
2. on-going interest and participation, and
3. differing personal beliefs.

Patient-centered research is needed to better understand what adolescents/families want in prevention initiatives, who should deliver program content, where and when to deliver programs in the community, and how adolescents/families wish to be informed of results. The investigators believe that by engaging patients and the community in the development process, the investigators will be able to obtain workable answers to these questions at a population level for high-risk youth/families in "real world" settings.

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Riley Children's Specialties
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine
    • Indianapolis, Indiana, United States, 46202
      • Riley Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Overweight (BMI >85th percentile for age and sex, weight for height >85th percentile, or weight >120% of ideal [50th percentile] for height)

2. At least two of the following risk factors:

   • Have been diagnosed with prediabetes;
   • Have a family history of T2DM in first- and second-degree relatives;
   • Belong to a minority race/ethnic group (Native Americans, African-Americans, Hispanic Americans, Asians/South Pacific Islanders);
   • Have conditions associated with insulin resistance; and/or
   • Have had gestational diabetes or were exposed to gestational diabetes in utero.
3. A family support person who is also willing to participate in the study. This person would preferably be a parent also at risk for diabetes (history of gestational diabetes, prediabetes, or with T2D).

Exclusion Criteria:

1. Type 2 diagnosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.	Behavioral: Encourage 2.0; Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1C		12 months
Physical activity	self-report	12 months
Quality of life	Pediatric Quality of Life Inventory	12 months
Intervention group session attendance		12 months
Dietary records	Semi-quantitative food frequency questionniare	12 months

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Indiana University Health
• Investigators: Principal Investigator: Tamara Hannon, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: February 23, 2016
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (Estimate): March 7, 2016

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: family; type 2 diabetes; prediabetes; Diabetes prevention
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
• Other Study ID Numbers: 1510313617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: undecided